Kornimate/medical-research-clean huggingface dataset:
the welcome incoming neighbor (win) community trial

Conditions: HIV

Summary: migration is common in rural africa: in-migrants have higher hiv incidence and prevalence than community residents, but underutilize combined hiv prevention and care services, including voluntary medical male circumcision and antiretroviral therapy, increasing the risks of hiv acquisition and onward transmission. uptake of combined hiv prevention (chp) is critical in this vulnerable population. the investigators will conduct a community randomized trial to rapidly identify and link migrants to chp in rural uganda; if effective, the intervention could be widely implemented as an important strategy towards hiv epidemic control.

the rakai health sciences program (rhsp), uganda, proposes an implementation science community- randomized controlled trial (crct) of a novel intervention to newly in-migrated individuals ("welcome incoming neighbor" \[win\]), to optimize in-migrated individuals' rapid linkage to combination hiv prevention (chp) services. rhsp data show that within the first 36 months after in-migration, compared to residents, hiv-negative in-migrants are at increased risk of hiv acquisition and hiv+ in-migrants underutilize antiretroviral therapy (art) increasing the risk of onward transmission. the theory-based win intervention includes community sensitization and community-based win scouts (wins). wins will conduct active community surveillance to rapidly identify and welcome in-migrants, provide the in-migrants with information about the availability of chp and high rates of use by residents (to "normalize" uptake), utilize a motivational interviewing approach to encourage chp adoption, refer in-migrants to free services, and follow-up in-migrants to assess and further encourage engagement in chp. specific aims: aim 1: to randomize 40 individually matched communities in a 1:1 ratio to the win intervention or control arm. in-migrants aged 15-49 in each arm will undergo a baseline and 2 follow-up surveys at \~18-month intervals. study end points are chp coverage rates, hiv incidence in initially hiv-negative in-migrants (n \~3,800 py per arm), and viral load suppression in hiv+ (n \~740 per arm). aim 2a: to use a mixed methods approach (in-depth interviews, process \& survey data) and reach, effectiveness, adoption, implementation, maintenance (re-aim) to (i) guide interim intervention adaptation as necessary; (ii) interpret trial results; and, (iii) translate the research into future action. aim 2b: to conduct cost studies to provide information on affordability and sustainability. innovation and impact: this novel intervention will rapidly engage a vulnerable priority population of in-migrants, to optimize chp and hiv impact in rural uganda.

Eligibility criteria:
inclusion criteria: * residing in study community exclusion criteria: * unable or unwilling to provide informed consent.
open versus laparoscopic repair of perforated peptic ulcer

Conditions: Perforated Peptic Ulcer

Summary: the aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at sohag university hospital. the study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.


Eligibility criteria:
inclusion criteria: * all patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with american society of anesthesiologists (asa) grade i, ii, iii. exclusion criteria: * patients with associated bleeding ulcer (additional steps are needed to control bleeding). * patients with associated pathology other than perforated peptic ulcer. * patients with american society of anesthesiologists (asa) grade iv, v, vi.
oropharyngeal administration of mother's colostrum for premature infants (ns-72393-360)

Conditions: Infection; Enterocolitis, Necrotizing; Ventilator-associated Pneumonia

Summary: extremely premature (bw\<1250g) infants are at high risk for morbidity and mortality. own mother's colostrum (omc) and milk (omm) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. the investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.

extremely premature (bw\<1250g) infants are at high risk for morbidity and mortality. own mother's colostrum (omc) and milk (omm) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. this 5-year placebo-controlled, double-blind randomized controlled trial will evaluate the safety, efficacy and health outcomes of oropharyngeal administration of omc/omm in a sample of 622 (total patients enrolled) extremely premature infants with the following aims: aim 1. to determine if oropharyngeal administration of omc/omm to extremely premature infants will reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. aim 2: to determine if extremely premature infants who receive omc/omm via the oropharyngeal route have a shorter time to reach full enteral feeds and a shorter length of hospital stay. aim 3: to determine if oropharyngeal administration of omc/omm will have immunostimulatory effects for extremely premature infants, as measured by (a) enhancement of gastrointestinal (fecal) microbiota, (b) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (c) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin. results will confirm whether extremely premature infants demonstrate a host-immune response to this intervention and whether there is a beneficial effect on common morbidities in these high risk patients.

Eligibility criteria:
inclusion criteria: birthweight \<1250g mother plans to pump and provide breastmilk for at least 2 months absence of severe congenital anomalies admission to the neonatal intensive care unit within 24 hours after birth ability to begin protocol within 96 hours of life exclusion criteria: gastrointestinal anomaly ph \< 7.0 on initial blood gas in nicu maternal +hiv status maternal drug or substance use that precludes infant from receiving mother's milk tracheoesophageal fistula

Keywords: oropharyngeal colostrum mother's milk premature neonate infection necrotizing enterocolitis ventilator-associated pneumonia breastmilk human milk late-onset sepsis microbiome antioxidant enteral feeds
cbd for lower urinary tract dysfunction in spinal cord injury

Conditions: Supra-sacral Spinal Cord Injury; Spinal Cord Injury; Urinary Incontinence

Summary: the goal of this feasibility study is to learn whether cannabidiol (cbd) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (sci). participants will take epidiolex (purified cbd) for 90 days

this pilot study assesses the feasibility of using 100mg of twice daily cannabidiol (epidiolex) in adult spinal cord injury with neurogenic lower urinary tract dysfunction following resolution of spinal shock.

Eligibility criteria:
inclusion criteria: * \>18 years of age * history of supra-sacral spinal cord injury of any mechanism * urinary incontinence with ≥2 episodes of urinary incontinence per day (outside of spinal shock) * willingness to participate in drug intervention trial * english-speaking (able to provide consent and complete questionnaires) exclusion criteria: * history of intravesical botox * actively taking \>15 mg of oxybutynin single dose or equivalent dose of alternative anticholinergic medication for bladder symptoms * use of cannabis (any form) outside of study as determined by urine drug screen after washout period of 1 month if prior cannabis use reported * thought or mood disorder aside from depression
liposomal bupivacaine vs continuous nerve catheters for below the knee amputations

Conditions: Pain, Postoperative; Amputation

Summary: through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at maine medical center, for the management of post-limb amputation pain. we will use the data that we collect to inform the design of a larger, appropriately powered study.

lower extremity amputation is a common surgical procedure often due to limb ischemia or complications related to diabetes mellitus. managing postoperative pain can be quite challenging in this patient population and persistent post-surgical pain is not uncommon. peripheral nerve catheters (pncs) that deliver a continuous infusion of local anesthetic have been shown to provide analgesic benefit dependent upon infusion duration and in the absence of catheter malfunction. unfortunately, pncs can be difficult to place and rates of dislodgement are estimated at 30%. single shot regional nerve blocks using liposomal bupivacaine are much easier to perform than pncs and can provide up to 72 hours of pain relief, eliminating the need for catheter placement. to date, no study has investigated the effects of liposomal bupivacaine compared to pncs for post-surgical pain control. in this pilot study, we intend to compare pain scores, opioid consumption, and length of stay in patients randomized to both treatment strategies. we also intend to conduct an exploratory analysis investigating incidence of phantom limb pain one month following surgery. our results will inform the design of a larger powered study to investigate treatment effects.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status classification i-iv * scheduled for primary amputation or stump revision * english speaking exclusion criteria: * patients unable to cooperate or consent to the study * allergy to local anesthetics * existing infection at planned needle insertion site * bmi \> 40kg/m2 * patients with a history of coagulopathy * emergency amputations * contralateral amputations * patients with a substance use disorder diagnosis * patients on opioids \>90 morphine milligram equivalents (mme)/day
use of vasopressin following the fontan operation

Conditions: Pleural Effusion; Single-ventricle

Summary: the purpose of this pilot study is to prepare for a larger study to determine whether vasopressin following the fontan operation will decrease chest tube output and duration.

a pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the fontan operation. phase one of the study will be a single center pilot study and will be conducted at advocate children's hospital, oak lawn il. this will be a randomized and double blinded. ten patients will be enrolled with five patients as control group and five receiving vasopressin. vasopressin levels will be obtained just prior to initiation of vasopressin and 48 hours later in the pilot study. safety and effect size will be evaluated after this pilot study. drug administration protocol: vasopressin at a dose of 0.4 mu/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. the dose of vasopressin will not be titrated. study drug drip will infuse for 48 hours after which will be discontinued. the placebo group will be receiving normal saline at the same rate of the vasopressin group. the treating physician will be blinded.

Eligibility criteria:
inclusion criteria: * subjects between 1.5-7 years old undergoing fontan operation. exclusion criteria: * patients with a planned fenestrated fontan. * patients undergoing revision surgery for failing fontan. * evidence of renal insufficiency prior to surgery defined by creatinine \>1 mg/dl. * planned arch reconstruction at the time of the fontan procedure
studies in patients with low anterior resection syndrome (lars)

Conditions: Anterior Resection Syndrome; Bowel Dysfunction

Summary: colorectal cancer is the commonest cancer diagnosed for both genders combined in hong kong. in 2015 16.6% of all new cancer cases registered on the hong kong registry were cancer of colon and rectum. with recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal or coloanal anastomosis to avoid permanent stoma. up to 80% of patients who has undergone low anterior resection (lar), suffer from severe bowel dysfunction post operatively. patients may suffer from a wide range of symptoms from incontinence, frequency, and urgency to constipation and feelings of incomplete emptying. this combination of symptoms after lar is referred to as low anterior resection syndrome (lars) which is associated with negative impact on quality of life (qol). originally, it was thought that these symptoms were due to early postoperative changes. many studies report that the majority of patients experience longterm changes in quality of life after lar. therefore, a large number of patients worldwide are suffering from unpredictable, poor bowel function postoperatively affecting their day-to-day activity and quality of life. the cause of lars is often multifactorial and difficult to define. unfortunately, there is no cure for lars at present. this trial is designed to use fecobionics, a new hong kong based innovation of a simulated stool, to provide new mechanistic insights regarding anorectal physiological function post low anterior resection to understand the condition better to improve their treatment options.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with history of lars over 3 months. * informed, written consent by the patient exclusion criteria: * patients who are not willing to undergo the specified tests in this study * pregnant women
cannabis edibles packaging descriptors experiment

Conditions: Cannabis Use

Summary: the purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without product descriptors of interest.

cannabis edibles are rapidly leading the legal recreational cannabis market. they present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of delta-9-tetrahydrocannabinol (thc). product packaging plays an important role in influencing perceptions of a product's appeal and potential harm. this experiment will assign participants to view real cannabis edibles packaging edited with one of nine commonly used product descriptors found on real cannabis edibles products, and ask a series of questions to assess perceptions of product appeal and harm. one group of participants will serve as the control and will see the same cannabis edibles packaging without any product descriptors.

Eligibility criteria:
inclusion criteria: * us resident * aged 18-65, inclusive * up to 13% of participants will be those who identify as black/african american * up to 16% of participants will be those who identify as hispanic * approximately 50% of participants will be past year cannabis users exclusion criteria: * does not currently reside in the united states * younger than 18 or older than 65 * does not provide information regarding history of cannabis use * otherwise eligible but demographic and/or user group quotas have been met

Keywords: cannabis use
the optimal sequential therapy after long term denosumab treatment

Conditions: Osteoporosis

Summary: this study intends to investigate whether alendronate and zoledronate can prevent bone mineral density loss after long-term treatment with denosumab.

this study intends to use a randomized trial to test whether alendronate and zoledronate can avoid the risk of rapid bone loss after the withdrawal of denosumab.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women or men over 50 years old 2. denosumab treatment for at least two years and less than three years (up to five doses). exclusion criteria: 1. estimated glomerular filtration rate \<35 ml/min. 2. malignancy 3. continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism 4. secondary osteoporosis 5. metabolic bone diseases 6. contraindications to zol 7. patients older than 80 years old 8. hypocalcemia

Keywords: osteoporosis denosumab alendronate zoledronic acid
phase ii trial of combination therapy with bevacizumab and s-1 in elderly patients with unresectable or recurrent colorectal cancer (basic)

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether s-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer


Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy 2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist) 3. patients with no previous treatment (radiotherapy or chemotherapy). patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment. 4. treatment with folfiri and folfox is not indicated. 5. age \>65 years 6. life expectancy of at least 3 months 7. ecog ps of 0, 1, or 2 8. adequate function of major organs as defined below: 1. hemoglobin \>9.0 g/dl 2. white blood cell count \>3,500/mm3, \<12,000/mm3 3. neutrophil count \>1,500/mm3 4. platelet count \>100,000/mm3 5. total bilirubin \<1.5 mg/dl 6. ast and alt \<100 u/l (\<200 u/l in patients with liver metastasis) 7. serum creatinine \<1.2 mg/dl 8. creatinine clearance estimate by the cockcroft-gault method \>50 ml/min 9. able to take capsules orally. 10. no electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator. 11. voluntary written informed consent. exclusion criteria: 1. serious drug hypersensitivity or a history of drug allergy 2. active double cancer 3. active infections (e.g., patients with pyrexia of 38℃ or higher) 4. uncontrolled hypertension 5. serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes) 6. moderate or severe ascites or pleural effusion requiring treatment 7. watery diarrhea 8. treatment with flucytosine 9. metastasis to the cns 10. pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. men who are currently attempting to conceive children. 11. severe mental disorder 12. continuous treatment with steroids 13. urine dipstick for proteinuria should be \<2+ 14. thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism 15. major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks 16. long-term daily treatment with aspirin (\>325 mg/day) 17. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 18. judged ineligible for participation in the study by the investigator for safety reasons.

Keywords: s-1 bevacizumab
practice variation on antithrombotics in covid-19

Conditions: COVID-19 Pneumonia; Thrombosis; COVID-19 Acute Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome (SARS) Pneumonia

Summary: evidence suggests coronavirus disease 2019 (covid-19) is associated with an increased incidence of thromboembolic manifestations. various guidelines on managing antithrombotics in covid-19 either provided conflicting guidance or unclear recommendations for post-discharge thromboprophylaxis. the investigators aim to collect the current practices in india among physicians on antithrombotic therapy for hospitalised patients with covid-19 and after discharge from the hospital.

immune dysregulation plays a crucial role in the development of severe coronavirus disease 2019 (covid-19). the autopsy of lungs in deceased covid-19 patients showed micro thrombosis and inflammatory infiltrates similar to acute respiratory distress syndrome (ards). reports of increased incidence of arterial or venous thrombosis with covid-19 made initial recommendations regarding using higher doses of anticoagulation. the markers of thrombosis like d-dimer, platelet count, fibrinogen are also increased in patients with covid-19 along with other inflammatory markers. the pathophysiology of coagulopathy of covid-19 is still under research. it is likely multi-factorial involving inflammation, hypoxia, endothelial dysfunction, direct viral cytopathic effect, platelets and complement activation, derangement of the renin-angiotensin-aldosterone pathway. from the inception of the pandemic, the physicians started using various antithrombotic with higher than prophylactic doses to treat the prothrombotic state. in the absence of clear guidance with conflicting evidence, there is considerable variation in the practices of physicians managing covid-19. the investigators are planning for a nationwide multicentre cross-sectional survey on understanding participating physicians practices on the choice of different antithrombotics available in india as of august 2021. the survey will have three sections: 1. demographics 2. antithrombotics in hospitalised patients 3. antithrombotics after discharge from the hospital the investigators intend to involve 1000 physicians from different specialities with the help of the steering committee.

Eligibility criteria:
inclusion criteria: • physicians involved in the management of adult hospitalised patients with covid-19 in india exclusion criteria: * pediatricians * physicians involved in the out-patient management of covid-19 * refused to participate

Keywords: anticoagulation in covid-19 anticoagulants sars-cov-2 coronavirus disease 2019 management of covid-19
a pilot drug trial that evaluates the whitening potential of nicotine gum

Conditions: Dental Pellicle

Summary: the purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. the study will enroll adults who have visible tooth staining.

this was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of nicorette freshmint gum. the subjects were assigned, per label instructions, to either nicorette freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group. a total of 3 study visits were planned: screening/baseline, week 2 and week 6. a telephone screening prior to baseline and the screening/baseline visit was performed to confirm subject eligibility. at each visit an oral examination, including a stain index measurement used to rate tooth-staining (macpherson modification of the lobene stain index), was conducted; and smoking status and motivation to quit smoking were assessed. the safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.

Eligibility criteria:
inclusion criteria: * daily smokers for at least one year * motivated to quit smoking * normal chewing ability * willing to refrain from a dental prophylaxis for the duration of the study * total extrinsic facial tooth stain score \> or = to 28, according to the macpherson modification of the lobene stain index exclusion criteria: * \< 20 natural teeth * inadequate oral hygiene

Keywords: tooth stain